ES2402881T5 - Minimally invasive heart valve with leaflet positioners - Google Patents
Minimally invasive heart valve with leaflet positioners Download PDFInfo
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- ES2402881T5 ES2402881T5 ES10164361T ES10164361T ES2402881T5 ES 2402881 T5 ES2402881 T5 ES 2402881T5 ES 10164361 T ES10164361 T ES 10164361T ES 10164361 T ES10164361 T ES 10164361T ES 2402881 T5 ES2402881 T5 ES 2402881T5
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- valve
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- heart valve
- prosthetic heart
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Classifications
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- A—HUMAN NECESSITIES
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
- A61F2/243—Deployment by mechanical expansion
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
- A61F2/2418—Scaffolds therefor, e.g. support stents
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- A—HUMAN NECESSITIES
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- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
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- A—HUMAN NECESSITIES
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- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
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- A—HUMAN NECESSITIES
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
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- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A—HUMAN NECESSITIES
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0008—Fixation appliances for connecting prostheses to the body
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- A—HUMAN NECESSITIES
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- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2220/0066—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements stapled
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
Landscapes
- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Vascular Medicine (AREA)
- Transplantation (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Heart & Thoracic Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Mechanical Engineering (AREA)
- Prostheses (AREA)
- External Artificial Organs (AREA)
Abstract
Description
DESCRIPCIÓNDESCRIPTION
Válvula de corazón mínimamente invasiva con posicionadores de valvaMinimally invasive heart valve with leaflet positioners
Campo del InventoInvention Field
El presente invento se refiere generalmente a los implantes médicos, y más particularmente, a válvulas de corazón compresibles/expansibles mínimamente invasivos y a métodos para colocar e implantar tales válvulas.The present invention relates generally to medical implants, and more particularly, to minimally invasive compressible / expandable heart valves and to methods of positioning and implanting such valves.
Antecedentes del InventoBackground of the Invention
Las válvulas de corazón protésicas se usan para sustituir las válvulas de corazón dañadas o enfermas. En los animales vertebrados el corazón es un órgano muscular hueco que tiene cuatro cámaras de bombeo: las aurículas izquierda y derecha y los ventrículos izquierdo y derecho, cada uno provisto de su propia válvula unidireccional. Las válvulas de corazón naturales son identificadas como la aórtica, la mitral (o bicúspide), la tricúspide y las válvulas pulmonares. Las válvulas de corazón protésicas pueden usarse para sustituir cualquiera de estas válvulas naturales aunque la reparación o sustitución de las válvulas aórtica o mitral es más común debido a que están situadas en el lado izquierdo del corazón lugar donde las presiones son las más altas.Prosthetic heart valves are used to replace damaged or diseased heart valves. In vertebrate animals the heart is a hollow muscular organ that has four pumping chambers: the left and right atria, and the left and right ventricles, each with its own one-way valve. Natural heart valves are identified as the aortic, mitral (or bicuspid), tricuspid, and pulmonary valves. Prosthetic heart valves can be used to replace any of these natural valves, although repair or replacement of the aortic or mitral valves is more common because they are located on the left side of the heart, where the pressures are highest.
Cuando está indicada la sustitución de una válvula de corazón, normalmente se corta la válvula deteriorada y se sustituye bien por una válvula mecánica, o por un tejido o válvula bioprotésica. A menudo se prefieren las válvulas de tipo bioprotésico más que las válvulas mecánicas debido a que normalmente no requieren un tratamiento a largo plazo con anticoagulantes. Las válvulas más comunes de tipo bioprotésico están hechas con válvulas totalmente porcinas (cerdos), o con aletas independientes cortadas de un pericardio bovino (vaca).When replacement of a heart valve is indicated, the impaired valve is usually excised and replaced by either a mechanical valve, or a bioprosthetic tissue or valve. Bioprosthetic type valves are often preferred over mechanical valves because they do not normally require long-term treatment with anticoagulants. The most common valves of the bioprosthetic type are made with entirely porcine valves (pigs), or with independent flaps cut from a bovine pericardium (cow).
Aunque se dispone de las llamadas válvulas sin endoprótesis, que comprenden una sección de un xenoinjerto de piel de aorta y de válvula (por ejemplo, porcino), entre las válvulas más ampliamente usadas se incluye algún tipo de soporte de aleta artificial. Tal soporte es un “armazón de soporte”, a veces llamado una “estructura de hilo metálico” o “endoprótesis”, que tiene una pluralidad (normalmente tres) de grandes valvas en forma de U que soportan la zona de la valva de las aletas del tejido bioprotésico (es decir, una válvula completa o tres aletas independientes). Los extremos libres de cada una de las dos valvas contiguas convergen en algún modo asintóticamente para formar unas comisuras verticales que terminan en puntas en forma de U, estando cada una curvada en la dirección opuesta a la de las valvas, y que tienen un radio relativamente más pequeño. El armazón de soporte describe normalmente un tubo cónico que con las puntas de la comisura en el extremo del diámetro pequeño. Esto proporciona una forma de referencia ondulante a la que se une un borde fijado de cada aleta (por medio de componentes tales como un tejido y suturas) muy parecido al esqueleto fibroso natural en el anillo aórtico. Por lo tanto, las valvas y comisuras alternantes se asemejan al contorno natural de una unión de aleta. De forma importante, la estructura de hilo metálico proporciona un soporte continuo para cada aleta a lo largo de la zona de la valva con objeto de simular mejor la estructura de un soporte natural.Although so-called stentless valves are available, comprising a section of a valve and aortic skin xenograft (eg, porcine), the most widely used valves include some type of artificial fin support. Such support is a "support frame", sometimes called a "wireframe" or "stent", which has a plurality (usually three) of large U-shaped leaflets that support the leaflet area of the fins. bioprosthetic tissue (i.e., a complete valve or three independent flaps). The free ends of each of the two adjoining leaflets converge in some way asymptotically to form vertical commissures that end in U-shaped points, each being curved in the opposite direction to that of the leaflets, and having a relatively relative radius. smaller. The support frame typically describes a conical tube with the commissure tips at the small diameter end. This provides an undulating reference shape to which a fixed edge of each fin is attached (via components such as tissue and sutures) much like the natural fibrous skeleton in the aortic annulus. Therefore, the alternating leaflets and commissures resemble the natural contour of a fin joint. Importantly, the wireframe structure provides continuous support for each fin along the leaflet area in order to better simulate the structure of a natural support.
El armazón de soporte es típicamente un material no ferromagnético tal como el ELGILOY (una aleación Co-Cr) que posee una elasticidad sustancial. Un método común de formación de armazones de soporte consiste en doblar un hilo metálico en un patrón ondulado plano (bidimensional) de las valvas y comisuras alternantes y después enrollar el patrón plano introduciéndolo en un tubo usando un rodillo cilíndrico. Los extremos libres de la forma tridimensional resultante, típicamente en la zona asintótica de las valvas, son después fijados conjuntamente usando un empalme tubular que es plásticamente doblado alrededor de los extremos. Véanse las Figuras 3 y 4 de la Patente de EEUU N° 6.296.662 sobre un armazón de soporte que está doblado conjuntamente en un punto medio de la valva.The support frame is typically a non-ferromagnetic material such as ELGILOY (a Co-Cr alloy) that possesses substantial elasticity. A common method of forming support frames is to bend a metallic wire into a flat (two-dimensional) wavy pattern of alternating leaflets and commissures and then roll the flat pattern into a tube using a cylindrical roller. The free ends of the resulting three-dimensional shape, typically in the asymptotic region of the leaflets, are then fixed together using a tubular joint that is plastically bent around the ends. See Figures 3 and 4 of US Patent No. 6,296,662 on a support frame that is folded together at a midpoint of the leaflet.
Algunas válvulas incluyen por diversos motivos “armazones de soporte” poliméricos más bien que metálicos. Por ejemplo, la Patente de EEUU N° 5.895.420 expone un armazón de soporte plástico que se degrada en el cuerpo con el paso del tiempo. A pesar de algunas propiedades favorables de los armazones de soporte poliméricos, por ejemplo la capacidad de amoldarse a la forma compleja del armazón de soporte, generalmente se prefieren los armazones de soporte metálicos convencionales por sus propiedades elásticas, y tienen un registro de seguimiento comprobado en válvulas de corazón altamente exitosas. Por ejemplo, la Válvula de Corazón Porcina CAPENTIER-EDWARDS y la Válvula de Corazón Pericardial disponible en Edwards Lifesciences LLC tienen ambas unos armazones de soporte ELGILOY y conjuntamente han disfrutado de una posición dominante en el mercado mundial desde 1976.Some valves include polymeric rather than metallic "support frames" for various reasons. For example, US Patent No. 5,895,420 discloses a plastic support frame that degrades in the body over time. Despite some favorable properties of polymeric support frames, for example the ability to conform to the complex shape of the support frame, conventional metal support frames are generally preferred for their elastic properties, and have a proven track record in highly successful heart valves. For example, the CAPENTIER-EDWARDS Porcine Heart Valve and the Pericardial Heart Valve available from Edwards Lifesciences LLC both have ELGILOY support frames and together have enjoyed a dominant position in the world market since 1976.
Una cirugía convencional de sustitución de una válvula del corazón implica acceder al corazón en la cavidad torácica del paciente a través de una incisión longitudinal en el pecho. Por ejemplo, una esternotomía media requiere el corte a través del esternón y forzar las dos mitades opuestas de la caja torácica para separarlas, para permitir el acceso a la cavidad torácica y al interior del corazón. El paciente es colocado a continuación en derivación cardiopulmonar, lo que implica parar el corazón para permitir el acceso a las cámaras interiores. Tal cirugía a corazón abierto es especialmente invasiva e implica un periodo de recuperación largo y difícil.Conventional heart valve replacement surgery involves accessing the heart into the patient's chest cavity through a longitudinal incision in the chest. For example, a median sternotomy requires cutting through the sternum and forcing the two opposing halves of the rib cage apart, to allow access to the chest cavity and the interior of the heart. The patient is then placed on cardiopulmonary bypass, which involves stopping the heart to allow access to the interior chambers. Such open heart surgery is especially invasive and involves a long and difficult recovery period.
Se han realizado algunos intentos para conseguir la colocación e implante menos traumáticos de las válvulas de corazón protésicas. Por ejemplo, la Patente de EEUU N° 4.056.854 de Boretos expone una válvula de corazón radialmente compresible fijada a una endoprótesis de muelle circular que puede ser comprimida para su colocación y expandida para fijarla en una posición de la válvula. También, la Patente N° 4.994.077 de Dobbin describe una válvula de corazón en forma de disco que está conectada a una endoprótesis radialmente compresible para su implante de una forma mínimamente invasiva.Some attempts have been made to achieve less traumatic placement and implantation of prosthetic heart valves. For example, US Patent No. 4,056,854 to Boretos discloses a radially compressible heart valve attached to a circular spring endoprosthesis that can be compressed for placement. and expanded to fix it in a position of the valve. Also, Patent No. 4,994,077 to Dobbin describes a disc-shaped heart valve that is connected to a radially compressible stent for implantation in a minimally invasive manner.
Recientemente se ha realizado una gran cantidad de investigación para reducir el trauma y riesgo asociados con la cirugía de sustitución de válvulas a corazón abierto. En particular, el campo de la cirugía mínimamente invasiva (MIS) ha surgido con fuerza desde la mitad de los años 90 con dispositivos que ahora están siendo disponibles para permitir las sustituciones de válvulas sin tener que abrir la cavidad torácica. La cirugía MIS de sustitución de una válvula de corazón todavía requiere el desvío, aunque la extirpación de la válvula nativa y la implantación de la válvula protésica se realizan a través de tubos o cánulas alargados, con la ayuda de endoscopios y de otras técnicas de visualización.A great deal of research has recently been done to reduce the trauma and risk associated with open heart valve replacement surgery. In particular, the field of minimally invasive surgery (MIS) has emerged strongly since the mid-1990s with devices now becoming available to allow valve replacements without having to open the chest cavity. MIS heart valve replacement surgery still requires bypass, although removal of the native valve and implantation of the prosthetic valve are performed through elongated tubes or cannulas, with the help of endoscopes and other visualization techniques. .
Algunos ejemplos de válvulas de corazón MIS se muestran en la Patente N° 5.411.552 de Anderson y otros, en la Patente de EEUU N° 5.980.570 de Simpson, en la Patente de EEUU N° 5.984.959 de Robertson y otros, en la Patente de EEUU N° 6.425.916 de Garrison y otros, y en la Publicación PCT N° WO 99/334142 de Vesely.Some examples of MIS heart valves are shown in Patent No. 5,411,552 to Anderson et al., In US Patent No. 5,980,570 to Simpson, in US Patent No. 5,984,959 to Robertson et al. in US Patent No. 6,425,916 to Garrison et al., and in PCT Publication No. WO 99/334142 to Vesely.
Aunque estos y otros dispositivos proporcionan diferentes modos de comprimir, colocar y después expandir una “válvula de corazón” en sí, ninguno de ellos da muchos detalles estructurales de la válvula propiamente dicha. Por ejemplo, la publicación de Vesely muestra una estructura de aleta de tejido de la técnica anterior en la Figura 1, y un armazón interior expansible del invento que tiene sujeciones de la endoprótesis en las Figuras 3A-3C. Las aletas están “montadas en las sujeciones 22 de la endoprótesis de una manera similar a la mostrada en la Figura 1”. De igual modo Anderson describe el montaje de una válvula porcina dentro de una endoprótesis “por medio de un número de suturas adecuado para formar la prótesis 9 de válvula de corazón mostrada en la Figura 2”. Tales exposiciones generales se detienen repentinamente en la explicación sobre cómo realizar una válvula de una forma que maximice la eficacia a largo plazo. En particular, los medios particulares de fijación de las aletas a la endoprótesis MIS son críticos para asegurar la integridad y la durabilidad de la válvula una vez implantada. Todas las válvulas MIS de la técnica anterior son inadecuadas a este respecto. Además, el uso de implantes expansibles o estructuras de hilo metálico de soporte convencionales es difícil en las válvulas MIS debido a la necesidad de comprimir la válvula hasta un paquete de colocación de un diámetro relativamente pequeño, lo cual significa unos retos en cuanto al material.Although these and other devices provide different ways of compressing, positioning, and then expanding a "heart valve" itself, none of them give many structural details of the valve itself. For example, the Vesely publication shows a prior art tissue fin structure in Figure 1, and an expandable inner frame of the invention having stent attachments in Figures 3A-3C. The wings are "mounted to the stent holders 22 in a manner similar to that shown in Figure 1". Similarly, Anderson describes the assembly of a porcine valve within an endoprosthesis "by means of a number of sutures suitable to form the prosthesis 9 of the heart valve shown in Figure 2". Such general statements stop suddenly at explaining how to make a valve in a way that will maximize long-term efficiency. In particular, the particular means of attaching the flaps to the MIS stent are critical to ensuring the integrity and durability of the valve once implanted. All prior art MIS valves are unsuitable in this regard. In addition, the use of conventional expandable implants or wire support structures is difficult in MIS valves due to the need to compress the valve to a relatively small diameter delivery package, which presents material challenges.
Algunas válvulas MIS de la técnica anterior están destinadas a ser usadas sin retirar las aletas de válvula naturales. A veces las aletas naturales están muy calcificadas y su retirada implica un alto riesgo de que algunas partículas de la placa vayan a la corriente sanguínea. Por lo tanto, algunas de las válvulas MIS están diseñadas para expandirse hacia fuera dentro del anillo y las aletas nativas, y para comprimir las aletas contra el anillo. La superficie relativamente irregular del anillo calcificado y de las aletas crea problemas de dimensionamiento y puede complicar los pasos de colocación y posicionamiento. Las válvulas MIS de la técnica anterior son esencialmente implantes expansibles tubulares mejorados con una válvula de xenoinjerto nativo. La metodología de implante es simplemente la técnica convencional de expansión de un balón o la de empuje de una versión autoexpansible desde el extremo de un catéter. Se proporciona o se considera un control mínimo sobre la colocación de la válvula.Some prior art MIS valves are intended to be used without removing the natural valve vanes. Sometimes the natural fins are very calcified and their removal implies a high risk that some particles of the plaque enter the bloodstream. Therefore, some of the MIS valves are designed to expand outward into the native ring and fins, and to compress the fins against the ring. The relatively uneven surface of the calcified ring and fins creates sizing problems and can complicate the placement and positioning steps. The prior art MIS valves are essentially tubular expandable implants enhanced with a native xenograft valve. The implantation methodology is simply the conventional technique of expanding a balloon or pushing a self-expanding version from the end of a catheter. Minimal control over valve placement is provided or considered.
A pesar de algunos avances en el diseño de las válvulas MIS sigue existiendo la necesidad de una válvula MIS que sea resistente y que tenga una metodología más flexible de colocación y de implantación.Despite some advancements in MIS valve design, there is still a need for a robust MIS valve that has a more flexible placement and implantation methodology.
Una anuloplastia aórtica con anillo de la técnica anterior es conocida por el documento US 6.231.602, que comprende un armazón semirrígido flexible.A prior art ring aortic annuloplasty is known from US 6,231,602, which comprises a flexible semi-rigid framework.
Una endoprótesis de la técnica anterior para sujetar una válvula de tejido cardíaco es conocida a partir del documento WO 96/40008, que comprende al menos una sujeción de soporte de comisura y al menos una estructura de soporte de seno, estando cada estructura de soporte de seno dispuesta entre, pero no funcionalmente conectada a, una sujeción de comisura adyacente.A prior art stent for securing a heart tissue valve is known from WO 96/40008, comprising at least one commissure support fixture and at least one sinus support structure, each support structure being of sinus arranged between, but not functionally connected to, an adjacent commissure clamp.
Sumario del InventoSummary of the Invention
El presente invento proporciona unas válvulas de corazón protésicas mejoradas que pueden ser implantadas de una forma mínimamente invasiva, aunque tienen también aspectos que la hacen útil para cirugías convencionales. Las válvulas aquí descritas proporcionan una opción de colocación altamente adaptativa y fácil de usar para cirujanos de corazón o cardiólogos debido a las características que facilitan la implantación. La válvula está diseñada para ser expulsada de un tubo de colocación en una zona de implante y después expandida y/o colocada en contacto con el tejido circundante sin estructuras de anclaje adicionales. Además, la válvula y los instrumentos para el implante permiten volver a posicionar e incluso volver a comprimir la válvula si es necesario.The present invention provides improved prosthetic heart valves that can be implanted in a minimally invasive manner, although they also have aspects that make them useful for conventional surgeries. The valves described herein provide a highly adaptive and easy-to-use placement option for heart surgeons or cardiologists due to the characteristics that facilitate implantation. The valve is designed to be expelled from a delivery tube in an implant site and then expanded and / or placed in contact with the surrounding tissue without additional anchoring structures. Additionally, the valve and implant instruments allow repositioning and even re-compression of the valve if necessary.
De acuerdo con la invención se proporciona una válvula de corazón protésica tal como se relata en la reivindicación 1.In accordance with the invention there is provided a prosthetic heart valve as set forth in claim 1.
Además, las características preferidas se relatan en las reivindicaciones dependientes. Furthermore, the preferred features are set forth in the dependent claims.
Breve descripción de los dibujosBrief description of the drawings
La Figura 1 es una vista parcial de una sección generalmente vertical del corazón de un paciente a través del ventrículo izquierdo y las válvulas de corazón asociadas, e ilustrando el procedimiento de implantación de una válvula protésica con base en un catéter del presente invento;Figure 1 is a partial view of a generally vertical section of the heart of a patient through the left ventricle and associated heart valves, and illustrating the procedure of implantation of a prosthetic valve based on a catheter of the present invention;
la Figura 2A es una vista de la sección vertical a través de un anillo aórtico y un ejemplo de válvula de corazón protésica del presente invento implantada en él;Figure 2A is a vertical sectional view through an aortic annulus and an exemplary prosthetic heart valve of the present invention implanted therein;
la Figura 2B es una vista en planta desde arriba de la válvula de corazón protésica implantada de la Figura 2A;Figure 2B is a top plan view of the implanted prosthetic heart valve of Figure 2A;
las Figuras 3A-3C son respectivamente unas vistas en planta desde arriba y en planta desde abajo de la válvula de corazón protésica de la Figura 2A;Figures 3A-3C are respectively top plan and bottom plan views of the prosthetic heart valve of Figure 2A;
la Figura 4 es una vista en planta de un armazón de soporte de válvula de corazón protésica del presente invento en una forma de pieza plegada bidimensional antes de la conversión en la forma final tridimensional; la Figura 5 es una vista en perspectiva del armazón de soporte de la válvula de corazón protésica de la Figura 4 en su forma final tridimensional con una estructura de aleta y los posicionadores de valva;Figure 4 is a plan view of a prosthetic heart valve support frame of the present invention in a two-dimensional folded part shape prior to conversion to the final three-dimensional shape; Figure 5 is a perspective view of the support frame of the prosthetic heart valve of Figure 4 in its final three-dimensional shape with a flap structure and leaflet positioners;
las Figuras 5A y 5B son vistas de una parte del armazón de soporte tridimensional de válvula de corazón de la Figura 5 que muestra configuraciones alternativas de posicionador de valva;Figures 5A and 5B are views of a portion of the three-dimensional heart valve support frame of Figure 5 showing alternative leaflet positioner configurations;
la Figura 6A es una vista en alzado de una válvula de corazón protésica parcialmente montada como en las Figuras 3A-3C;Figure 6A is an elevational view of a partially assembled prosthetic heart valve as in Figures 3A-3C;
la Figura 6B es una vista en alzado de la válvula de corazón protésica de la Figura 6A totalmente montada; la Figura 7 es una vista en planta de un ejemplo de aleta usada en válvulas de corazón protésicas del presente invento;Figure 6B is an elevational view of the fully assembled prosthetic heart valve of Figure 6A; Figure 7 is a plan view of an exemplary flap used in prosthetic heart valves of the present invention;
la Figura 8 es un vista de la sección parcial de una zona de comisura de la válvula de corazón protésica tomada a lo largo de la línea 8-8 de la Figura 3B;Figure 8 is a partial sectional view of a prosthetic heart valve commissure area taken along line 8-8 of Figure 3B;
la Figura 9 es una vista de la sección a través de una parte del armazón de soporte del ejemplo de válvula de corazón protésica tomada a lo largo de la línea 9-9 de la Figura 8;Figure 9 is a sectional view through a portion of the support frame of the example prosthetic heart valve taken along line 9-9 of Figure 8;
la Figura 10 es una vista de la sección a través de una zona de la punta de la comisura del ejemplo de válvula de corazón protésica, tomada a lo largo de la línea 10-10 de la Figura 8;Figure 10 is a sectional view through an area of the tip of the commissure of the example prosthetic heart valve, taken along line 10-10 of Figure 8;
la Figura 11 es una vista en perspectiva esquemática de un armazón de soporte de una válvula de corazón protésica del presente invento siendo cargada en un catéter de colocación;Figure 11 is a schematic perspective view of a prosthetic heart valve support frame of the present invention being loaded into a delivery catheter;
la Figura 12 es una vista en perspectiva del armazón de soporte después de haber sido cargada en un catéter de colocación;Figure 12 is a perspective view of the support frame after it has been loaded into a delivery catheter;
las Figuras 13A-13B son vistas en perspectiva y en alzado de un ejemplo de un elemento de sujeción de válvula de corazón compresible/expansible fijada a una válvula de corazón protésica del presente invento; la Figura 14 es una vista en perspectiva de la expulsión de una válvula y un elemento de sujeción de corazón protésicas como en las Figuras 13A y 13B desde el extremo distal de un catéter de colocación;Figures 13A-13B are perspective elevational views of an example of a compressible / expandable heart valve fastener attached to a prosthetic heart valve of the present invention; Figure 14 is a perspective view of the ejection of a prosthetic heart valve and fastener as in Figures 13A and 13B from the distal end of a delivery catheter;
la Figura 15 es una vista en planta desde abajo de un ejemplo de un elemento de sujeción de válvula de corazón compresible/expansible del presente invento;Figure 15 is a bottom plan view of an example of a compressible / expandable heart valve fastener of the present invention;
la Figura 16 es una vista en planta de una parte con varios brazos del elemento de sujeción de la Figura 15; yFigure 16 is a plan view of a multi-arm portion of the clamp member of Figure 15; and
las Figuras 17A-17B son dos vistas de una parte rígida del elemento de sujeción de la Figura 15.Figures 17A-17B are two views of a rigid part of the clamping element of Figure 15.
Descripción de las realizaciones preferidasDescription of the preferred embodiments
El presente invento proporciona un armazón de soporte de válvula mínimamente invasivo (MIS), válvula MIS, y unos métodos de realización y de colocación aquí descritos y mostrados en los dibujos que se acompañan.The present invention provides a minimally invasive valve support frame (MIS), MIS valve, and methods of embodiment and placement described herein and shown in the accompanying drawings.
El invento corresponde principalmente a válvulas de corazón de aletas flexibles y a armazones de soporte internos, los cuales se denominan en la técnica anterior implantes expansibles o estructuras de hilo metálico. Como se ha mencionado antes, las aletas flexibles pueden estar formadas por un material biológico (por ejemplo, un pericardio bovino) o un material sintético. En este contexto un “armazón de soporte” para una válvula de corazón de aleta flexible proporciona el soporte estructural interno primario de las aletas, y sustancialmente se parece al esqueleto fibroso natural del respectivo anillo de la válvula. Más específicamente, cada una de las aletas tiene un borde exterior que está acoplado a una parte del armazón de soporte de forma que su borde interior izquierdo sea libre para moverse dentro del área del orificio de la válvula, proporcionando de este modo las superficies de abertura y de cierre de ella. Una válvula de xenoinjerto biológico puede ser usada para proporcionar las aletas flexibles en las válvulas del presente invento, aunque el armazón de soporte interno es particularmente adecuado para recibir aletas individuales.The invention relates primarily to flexible flap heart valves and internal support frames, which are referred to in the prior art as expandable implants or wire structures. As mentioned before, the flexible fins can be formed of a biological material (eg, a bovine pericardium) or a synthetic material. In this context a "support frame" for a flexible flap heart valve provides the primary internal structural support of the flaps, and substantially resembles the natural fibrous skeleton of the respective valve annulus. More specifically, each of the flaps has an outer edge that is coupled to a portion of the support frame so that its left inner edge is free to move within the valve hole area, thereby providing the opening surfaces. and closing it. A biological xenograft valve can be used to provide the flexible flaps in the valves of the present invention, although the internal support frame is particularly suitable for receiving individual flaps.
Los armazones de aleta del presente invento tienen una forma ondulante continua con tres zonas de valva en forma de U en el extremo de entrada separadas por tres zonas de comisura verticales y generalmente orientadas axialmente o en forma de U en el extremo de salida. Alrededor de la circunferencia del armazón de aleta la forma tiene una estructura alternativa de valva-comisura-valva-comisura-valva-comisura, y generalmente describe una superficie cónica de revolución con las tres comisuras en el extremo de salida de la válvula estando más próximas entre sí que las tres valvas. Algunos armazones de soporte pueden alternativamente describir una superficie tubular de revolución alrededor de un eje. Las zonas de valva y las zonas de comisura están uniformemente distribuidas alrededor de un eje de flujo a través del armazón de soporte, y por lo tanto las tres zonas de valva están separadas 120° una de otra, y cada una de las tres zonas de comisura está separada 120° de la siguiente y 60° de la zona de valva contigua.The fin frames of the present invention have a continuous undulating shape with three U-shaped leaflet zones at the inlet end separated by three vertical commissure zones and generally axially oriented or U-shaped at the outlet end. Around the circumference of the flap frame the shape has an alternate leaflet-commissure-leaflet-commissure-leaflet-commissure structure, and generally describes a conical surface of revolution with the three commissures at the valve outlet end being closest each other than the three leaflets. Some support frames may alternatively describe a tubular surface of revolution about an axis. The leaflet zones and commissure zones are evenly distributed around an axis of flow through the support frame, and therefore the three leaflet zones are separated. 120 ° from each other, and each of the three commissure zones is separated 120 ° from the next and 60 ° from the contiguous leaflet zone.
El término “continuo” para describir el armazón de aleta de la valva de corazón significa que una línea continua y de forma cerrada (por ejemplo, un bucle) puede trazarse siguiendo las zonas secuenciales de valva y comisura, y “ondulante” se refiere a la forma de serpentina o alternante sinusoidal de la línea. Más generalmente, un armazón de aleta de la válvula de corazón ondulante se aproxima a la forma del tejido fibroso natural alrededor del anillo de la válvula aórtica a fin de parecerse a esa estructura de soporte natural para una funcionalidad óptima de las aletas protésicas.The term "continuous" to describe the fin framework of the heart leaflet means that a continuous and closed line (eg, a loop) can be drawn following the sequential leaflet and commissure zones, and "undulating" refers to the serpentine or alternating sinusoidal shape of the line. More generally, an undulating heart valve flap frame approximates the shape of the natural fibrous tissue around the aortic valve annulus to resemble that natural support structure for optimal prosthetic flap functionality.
El presente invento pertenece principalmente a las válvulas de corazón protésicas apropiadas para una colocación e implantación mínimamente invasiva. Tales válvulas mínimamente invasivas son capaces de ser comprimidas o aplastadas hasta un perfil pequeño y colocadas mediante un catéter o cánula (un tubo) en el sitio de implantación para la expansión a distancia y anclaje al mismo. Sin embargo, deberá entenderse que ciertos aspectos del invento aquí descritos son en general beneficiosos para las válvulas de corazón protésicas, y así no todas las reivindicaciones deberían considerarse como que requieren una válvula mínimamente invasiva.The present invention pertains primarily to prosthetic heart valves suitable for minimally invasive placement and implantation. Such minimally invasive valves are capable of being compressed or crushed to a small profile and placed via a catheter or cannula (a tube) at the implantation site for remote expansion and anchorage thereto. However, it should be understood that certain aspects of the invention described herein are generally beneficial to prosthetic heart valves, and thus not all claims should be construed as requiring a minimally invasive valve.
La Figura 1 representa una parte de un corazón de un paciente con el ventrículo izquierdo LV, la válvula aórtica AV, la válvula mitral MV, y la aorta ascendente AA mostrados en sección. Un catéter o tubo 20 de colocación se ve en posición justo antes de realizar la expulsión y expansión de la válvula de corazón protésica 22 desde un extremo distal de ella para su implante en el anillo de la válvula aórtica AV. Las aletas L de la válvula aórtica AV pueden primero ser extirpadas antes del implante de la válvula 22, o más preferiblemente las aletas L permanecen en su sitio y son expandidas hacia fuera y comprimidas contra la luz del anillo de la válvula aórtica AV tras la expansión de la válvula. El extremo distal del tubo de colocación 20 puede opcionalmente ser estabilizado por un balón 24 (mostrado superpuesto en líneas de puntos) inflado contra la luz de la aorta ascendente AA, o mediante otros medios. El tubo de colocación 20 es preferiblemente insertado en la vasculatura del paciente usando un introductor 26 de un diámetro mayor a través del vaso periférico tal como la arteria femoral o la vena femoral. Alternativamente, el vaso periférico puede ser la vena yugular interna, la arteria subclaviana, la arteria axilar, la aorta abdominal, la aorta descendente, o cualquier otro vaso sanguíneo apropiado. El introductor 26 puede ser insertado mediante un corte quirúrgico o percutáneamente usando la técnica de Seldinger.Figure 1 represents a part of a heart from a patient with the LV left ventricle, AV aortic valve, MV mitral valve, and AA ascending aorta shown in section. A delivery catheter or tube 20 is seen in position just prior to ejection and expansion of the prosthetic heart valve 22 from a distal end thereof for implantation in the annulus of the AV aortic valve. The flaps L of the AV aortic valve may first be excised prior to implantation of the valve 22, or more preferably the flaps L remain in place and are expanded outwardly and compressed against the lumen of the AV aortic valve annulus after expansion. from valvule. The distal end of the delivery tube 20 may optionally be stabilized by a balloon 24 (shown superimposed in dotted lines) inflated against the lumen of the ascending aorta AA, or by other means. The delivery tube 20 is preferably inserted into the patient's vasculature using an introducer 26 of a larger diameter through the peripheral vessel such as the femoral artery or femoral vein. Alternatively, the peripheral vessel can be the internal jugular vein, the subclavian artery, the axillary artery, the abdominal aorta, the descending aorta, or any other appropriate blood vessel. Introducer 26 can be inserted via a surgical cut or percutaneously using the Seldinger technique.
Las Figuras 2A y 2B ilustran la válvula de corazón protésica 22 implantada en el anillo de la válvula aórtica AV. La válvula de corazón 22 incluye tres valvas 30 en un extremo de la entrada (uno de los cuales no es visible) y tres comisuras 32 en un extremo de la salida. La dirección del flujo de la sangre BF está indicado con una flecha en la aorta ascendente AA. Las aletas naturales están convenientemente comprimidas contra la luz del anillo de la válvula aórtica por la válvula de corazón protésica 22, como se ve en la Figura 2B. La válvula 22 está orientada con respecto a un eje de flujo de forma que las comisuras 32 están generalmente alineadas con las comisuras nativas C, en tanto que las valvas (no mostradas pero intermedias entre las comisuras 32) están generalmente alineadas con las valvas/aletas naturales L. La válvula de corazón 22 hace contacto con la pared de la luz del anillo AV de la válvula aórtica y convenientemente mantiene su posición debido a la fricción entre ellos. En este aspecto la válvula de corazón 22 se expande desde su configuración de colocación mostrada en la Figura 1 a la configuración expandida en las Figuras 2A y 2B.Figures 2A and 2B illustrate the prosthetic heart valve 22 implanted in the annulus of the AV aortic valve. Heart valve 22 includes three leaflets 30 at one end of the inlet (one of which is not visible) and three commissures 32 at one end of the outlet. The direction of blood flow BF is indicated by an arrow in the ascending aorta AA. The natural flaps are conveniently compressed against the lumen of the aortic valve annulus by prosthetic heart valve 22, as seen in Figure 2B. Valve 22 is oriented relative to an axis of flow such that commissures 32 are generally aligned with native commissures C, while leaflets (not shown but intermediate between commissures 32) are generally aligned with leaflets / fins. natural L. Heart valve 22 makes contact with the lumen wall of the AV annulus of the aortic valve and conveniently maintains its position due to friction between them. In this regard, heart valve 22 expands from its placement configuration shown in Figure 1 to the expanded configuration in Figures 2A and 2B.
La válvula 22 hace contacto con la pared de la luz alrededor de toda la periferia de la entrada de ella y en ciertas áreas contiguas a la periferia de la entrada como se explicará más adelante. La periferia de la entrada está definida por los extremos inferiores de las valvas 30 así como por los extremos inferiores de los tres conectores 40 de las valvas que se extienden entre y llenan los espacios entre las valvas 30. Adicionalmente, la válvula de corazón 22 incluye tres posicionadores de valva 42, dos de los cuales son visibles en la Figura 2A, que están fijados rígidamente con respecto a un armazón interno de soporte de la válvula y están situados generalmente en el extremo de la salida de la válvula en medio de dos de las comisuras 32. Con referencia a la Figura 2B, los posicionadores de valva 42 están uniformemente distribuidos alrededor de un eje de flujo central 44, y cuando están implantados se alinean con las aletas nativas L. Los posicionadores de valva 42 se extienden preferiblemente de forma radial más hacia fuera que las comisuras 32 y comprimen las aletas L contra las cavidades del seno formadas precisamente encima del anillo de la válvula aórtica AV. La ostia coronaria CO abierta desde dos de las tres cavidades del seno, como se ve en la Figura 2A, y los tres posicionadores de valva 42 están dimensionados y situados por el operador para impedir un flujo de oclusión a través de la ostia coronaria CO. Más adelante se explicará con detalle la estructura y función ventajosas de estos posicionadores 42.Valve 22 contacts the lumen wall around the entire periphery of the inlet thereof and in certain areas adjoining the periphery of the inlet as will be explained later. The periphery of the inlet is defined by the lower ends of the leaflets 30 as well as the lower ends of the three leaflet connectors 40 that extend between and fill the spaces between the leaflets 30. Additionally, the heart valve 22 includes Three leaflet positioners 42, two of which are visible in Figure 2A, which are rigidly fixed with respect to an internal valve support frame and are located generally at the valve outlet end in the middle of two of the commissures 32. Referring to Figure 2B, the leaflet positioners 42 are evenly distributed about a central flow axis 44, and when implanted they align with the native flaps L. The leaflet positioners 42 preferably extend in a radial further outward than commissures 32 and compress flaps L against sinus cavities formed just above the annulus of the AV aortic valve. The CO coronary ostia open from two of the three sinus cavities, as seen in Figure 2A, and the three leaflet positioners 42 are sized and positioned by the operator to prevent occlusion flow through the CO coronary ostia. The advantageous structure and function of these positioners 42 will be explained in detail later.
Con referencia ahora a las Figuras 3A-3C, el ejemplo de válvula de corazón protésica 22 se describirá más completamente. La forma de un armazón interno de soporte 50 visto en la Figura 5 rige generalmente la forma de la válvula 22. Como se ha mencionado, la válvula 22 incluye las valvas 30 y comisuras 32 antes mencionadas distribuidas uniformemente alrededor de un eje de flujo 44. Las valvas 30 y los conectores de valva 40 definen una periferia de la entrada ondulada de la válvula 22, mientras que la periferia de la salida está definida por las tres comisuras 32 y los tres posicionadores de valva 42. Todo el armazón interno de soporte 50 excepto de los posicionadores de valva 42 está cubierto de una o más capas de material, de las que la capa exterior es típicamente un tejido como el mostrado (pero no numerado). El uso de un tejido tal como el tereftalato de polietileno proporciona una matriz en la cual el tejido circundante puede crecer para ayudar al anclaje de la válvula en el lugar.Referring now to Figures 3A-3C, the example prosthetic heart valve 22 will be more fully described. The shape of an internal support frame 50 seen in Figure 5 generally governs the shape of valve 22. As mentioned, valve 22 includes the aforementioned leaflets 30 and commissures 32 evenly distributed around a flow axis 44. The leaflets 30 and the leaflet connectors 40 define a periphery of the corrugated inlet of the valve 22, while the periphery of the outlet is defined by the three commissures 32 and the three leaflet positioners 42. The entire internal support frame 50 except for the valve positioners 42 it is covered with one or more layers of material, of which the outer layer is typically a fabric as shown (but not numbered). The use of a tissue such as polyethylene terephthalate provides a matrix in which the surrounding tissue can grow to help anchor the valve in place.
Tres aletas flexibles 52 montan sobre la valva 22 en una configuración de tres hojas con sus bordes libres 53 dispuestos para juntarse o encajar conjuntamente en el centro de la válvula y proporcionar una oclusión unidireccional. Un borde exterior de cada aleta 52 se fija a la válvula 22 entre dos de las comisuras 32 y alrededor de una de las valvas 30. A continuación se describirá un ejemplo de fijación estructural de las aletas 52 al armazón interno de soporte 50.Three flexible flaps 52 mount on the leaflet 22 in a three-bladed configuration with their free edges 53 arranged to meet or snap together in the center of the valve and provide unidirectional occlusion. An outer edge of each flap 52 is attached to valve 22 between two of the commissures 32 and around one of the leaflets 30. An example of structural attachment of flaps 52 to internal support frame 50 will now be described.
Como se ha mencionado, cada conector de valva 40 se extiende entre dos de las valvas 30. Un panel de tejido o de otro material 54 cubre un área entre la entrada o borde inferior de cada conector de valva 40 y las correspondientes comisuras 32. Parte de este panel de tejido 54 hace contacto convenientemente con la pared de la luz del anillo de la válvula aórtica AV para ayudar a impedir la filtración alrededor de la válvula.As mentioned, each leaflet connector 40 extends between two of the leaflets 30. A panel of tissue or other material 54 covers an area between the entrance or lower edge of each leaflet connector 40 and the corresponding commissures 32. Part of this tissue panel 54 conveniently contacts the lumen wall of the AV aortic valve annulus to help prevent leakage around the valve.
Los posicionadores de valva 42 tiene cada uno una forma de U invertida con un ápice apuntando hacia el extremo de salida de la válvula 22 y dos patillas que se extienden generalmente hacia el extremo de entrada y que conectan con el resto de la válvula. El término “forma en U” tiene como fin cubrir todas las configuraciones que tienen dos patillas y un ápice entre ellas. Otras descripciones figurativas tales como “forma en V”, “forma de campana”, sinusoidal, arqueada, o similares están por tanto incluidas en el término “forma en U”. Los posicionadores de valva 42 proporcionan a la válvula tres puntos de contacto con el tejido circundante que está a medio camino entre las tres comisuras 32 para ayudar a estabilizar y anclar la válvula en su posición de implante. Además, los posicionadores de valva 42 convenientemente realizan la función de comprimir las aletas nativas L hacia fuera contra las cavidades del seno, al menos en los procedimientos en los que las aletas L no han sido extirpadas.The leaflet positioners 42 each have an inverted U-shape with one apex pointing toward the outlet end of valve 22 and two legs extending generally toward the inlet end and connecting with the remainder of the valve. The term "U-shape" is intended to cover all configurations that have two pins and an apex between them. Other figurative descriptions such as "V-shape", "bell-shape", sinusoidal, arcuate, or the like are therefore included in the term "U-shape". The leaflet positioners 42 provide the valve with three points of contact with the surrounding tissue that is midway between the three commissures 32 to help stabilize and anchor the valve in its implant position. Furthermore, the leaflet positioners 42 conveniently perform the function of compressing the native flaps L outwardly against the sinus cavities, at least in procedures where the flaps L have not been excised.
Las aletas L en una válvula enferma pueden ser menos que flexibles, y ciertamente pueden estar muy calcificadas. A menudo se ha considerado preferible evitar la retirada de las aletas L para no tener que perturbar la calcificación u otro material estenótico que se haya formado alrededor de las aletas. Por lo tanto, el presente invento proporciona de forma deseable una estructura que comprime las hojas nativas L hacia fuera contra las cavidades del seno de la pared aórtica y mantienen las aletas en esa posición para impedir el aleteo y la potencial interferencia con el flujo sanguíneo a través de la válvula protésica. Se cree que la forma en U invertida de los posicionadores de valva 42 proporcionan una estructura efectiva al anclaje de la válvula en el anillo de la válvula aórtica AV y también controlan, o circunscriben, si se quiere, las aletas nativas obsoletas L. Al mismo tiempo, los posicionadores de valva 42 son relativamente mínimos en el área total para evitar la indebida interferencia con el reflujo de sangre en el lado del flujo de salida de cada una de las aletas 52, o hacia la ostia coronaria CO. Por lo tanto, los posicionadores de valva 42 están de forma deseable definidos por unos miembros relativamente delgados, como se muestra, opuestos a las paredes o paneles, o similares. Son posibles varios posicionadores de valva 42 por valva 30 de válvula, aunque el volumen sólido total ocupado por los posicionadores debería ser mantenido en un mínimo con el fin de minimizar el riesgo de ocluir la ostia coronaria CO.The L flaps on a diseased valve can be less than flexible, and can certainly be heavily calcified. It has often been considered preferable to avoid removal of the flaps L so as not to disturb the calcification or other stenotic material that has formed around the flaps. Therefore, the present invention desirably provides a structure that compresses the native L leaves outward against the sinus cavities of the aortic wall and holds the fins in that position to prevent flapping and potential interference with blood flow to through the prosthetic valve. The inverted U-shape of the leaflet positioners 42 is believed to provide an effective structure to anchoring the valve in the annulus of the AV aortic valve and also control, or circumscribe, if desired, the obsolete native flaps L. At the same time Over time, the leaflet positioners 42 are relatively minimal in total area to avoid undue interference with the backflow of blood on the outflow side of each of the flaps 52, or towards the coronary ostia CO. Thus, the leaflet positioners 42 are desirably defined by relatively thin members, as shown, opposed to walls or panels, or the like. Several leaflet positioners 42 are possible per valve leaflet 30, although the total solid volume occupied by the positioners should be kept to a minimum in order to minimize the risk of occluding the coronary ostia CO.
La altura axial de los posicionadores de valva 42 con relación a las comisuras 32 es vista mejor en la Figura 2A (y en la Figura 6B). Preferiblemente, las comisuras 32 son ligeramente más altas que los posicionadores de valva 42, aunque tal disposición no se considera obligatoria. La principal consideración sobre el tamaño de los posicionadores de valva 42 es evitar la oclusión de la ostia coronaria CO. Por lo tanto, como se ve en la Figura 2A, los posicionadores de valva 42 hacen contacto con la pared de la luz de la válvula aórtica circundante justo debajo de la ostia coronaria CO. Por supuesto que la anatomía de cada paciente difiere ligeramente de la del siguiente, y de la posición exacta de la ostia coronaria CO no puede ser predicha con una absoluta certeza. Además, la posición final de los posicionadores de valva 42 depende de la habilidad del cirujano de corazón o cardiólogo. Sin embargo, en la situación ideal los posicionadores de valva 42 están situados justo debajo y alineados circunferencialmente con la ostia coronaria CO tal como se ve en las Figuras 2A y 2B.The axial height of the leaflet positioners 42 relative to commissures 32 is best seen in Figure 2A (and Figure 6B). Preferably, the commissures 32 are slightly higher than the leaflet positioners 42, although such an arrangement is not considered mandatory. The main consideration regarding the size of the leaflet positioners 42 is to avoid occlusion of the coronary ostia CO. Thus, as seen in Figure 2A, the leaflet positioners 42 make contact with the lumen wall of the surrounding aortic valve just below the CO coronary ostia. Of course, the anatomy of each patient differs slightly from that of the next, and the exact position of the CO coronary ostia cannot be predicted with absolute certainty. Furthermore, the final position of the leaflet positioners 42 depends on the skill of the heart surgeon or cardiologist. However, in the ideal situation the leaflet positioners 42 are located just below and circumferentially aligned with the coronary ostia CO as seen in Figures 2A and 2B.
Las Figuras 2B y 3B-3C ilustran la posición radial hacia a fuera relativa de los posicionadores de valva 42 con respecto a las comisuras 32 entre ellos, y con respecto a los conectores de valva 40. Como se ha visto en la vista aislada del armazón de soporte 50 de la válvula de corazón en la Figura 5, los posicionadores de valva 42 están en ángulo o acampanados hacia fuera desde el resto del armazón de soporte. Este acampanamiento hacia fuera ayuda a asegurar un buen contacto entre el ápice de los posicionadores de valva 42 y las paredes circundantes de las cavidades del seno de la válvula aórtica AV. A este respecto la configuración exterior de la válvula de corazón 22 está diseñada para maximizar el contacto con la pared de la luz de la válvula aórtica AV en el anillo y para una corta distancia en cada cavidad del seno. Este contacto superficial extensivo entre la válvula protésica 22, y el tejido circundante puede evitar la necesidad de suturas, grapas, puntas de arpón agudas u otra estructura de anclaje de este tipo, aunque tal estructura podría ser usada en conexión con la valva. La válvula 22 es simplemente expulsada del extremo del tubo de colocación 20 (Figura 1) expandida con o sin la ayuda de un balón, y mantenida en posición por el contacto de fricción entre la periferia de la entrada con el anillo, y entre los posicionadores de valva 42 y las cavidades del seno (o las aletas nativas que intervienen).Figures 2B and 3B-3C illustrate the relative outward radial position of the leaflet positioners 42 with respect to the commissures 32 between them, and with respect to the leaflet connectors 40. As seen in the isolated view of the frame of heart valve support 50 in Figure 5, the leaflet positioners 42 are angled or flared outward from the remainder of the support frame. This outward flare helps to ensure good contact between the apex of the leaflet positioners 42 and the surrounding walls of the sinus cavities of the AV aortic valve. In this regard, the outer configuration of heart valve 22 is designed to maximize contact with the wall of the AV aortic valve lumen in the annulus and for a short distance in each sinus cavity. This extensive surface contact between prosthetic valve 22, and surrounding tissue may avoid the need for sutures, staples, sharp harpoon tips, or other such anchoring structure, although such a structure could be used in connection with the leaflet. Valve 22 is simply ejected from the end of placement tube 20 (Figure 1) expanded with or without the aid of a balloon, and held in position by frictional contact between the periphery of the inlet with the ring, and between the positioners. valve 42 and sinus cavities (or the native fins involved).
Cada posicionador de valva 42 incluye además al menos un miembro antimigración 56 rígidamente fijado a él y diseñado para ayudar al anclaje del armazón de soporte 50 al tejido circundante. En la realización ilustrada los miembros antimigración 56 preferiblemente incluye cada uno de ellos una sección alargada 58 que termina en una cabeza alargada y redondeada 60, pareciendo la configuración en algún modo a una cuchara. El miembro antimigración 56 sobresale convenientemente fuera del plano definido por el posicionador de valva 42 asociado, y puede extenderse de forma general axialmente en la dirección de entrada desde su ápice, como se ve en la Figura 3A. Cuando la válvula 22 está implantada, los miembros antimigración 56 están diseñados para hacer contacto y quedar en algún modo atrapados en las aletas nativas. Por lo tanto, los miembros antimigración 56 actúan como una punta de arpón redondeada a fin de mantener la válvula 22 en su posición de implante. El miembro 56 también puede ayudar a impedir el aleteo de las aletas nativas en el flujo sanguíneo turbulento. Se han considerado numerosas otras configuraciones, siendo la idea general que el miembro antimigración 56 mejore la capacidad del posicionador de valvas asociado 42 de anclarse en el tejido circundante. A este respecto, el término “miembro antimigración” está pensado para incluir cualquier estructura que mejore tal anclaje, que incluye las estructuras romas y las afiladas (es decir, las puntas de arpón).Each leaflet positioner 42 further includes at least one anti-migration member 56 rigidly attached thereto and designed to aid in anchoring the support frame 50 to surrounding tissue. In the illustrated embodiment the Anti-migration members 56 preferably each include an elongated section 58 terminating in an elongated, rounded head 60, the configuration somewhat resembling a spoon. The anti-migration member 56 conveniently protrudes out of the plane defined by the associated leaflet positioner 42, and may extend generally axially in the direction of entry from its apex, as seen in Figure 3A. When valve 22 is implanted, anti-migration members 56 are designed to contact and somehow become trapped in native flaps. Therefore, the anti-migration members 56 act as a rounded barb tip to maintain the valve 22 in its implantation position. Member 56 can also help prevent flapping of native fins in turbulent blood flow. Numerous other configurations have been considered, the general idea being that the anti-migration member 56 enhances the ability of the associated leaflet positioner 42 to anchor in surrounding tissue. In this regard, the term "anti-migration member" is intended to include any structure that enhances such anchorage, including blunt and sharp structures (ie, harpoon tips).
En la Figura 4 se describen con más detalle diversos procedimientos y aparatos para convertir una pieza plegada bidimensional, tal como la mostrada en la Figura 4, en la forma tridimensional de la Figura 5 en la Solicitud de Patente Serie N° 10/251.651, presentada el 20 de septiembre de 2002de EEUU en trámite, y titulada Armazón de soporte continuo de válvula de corazón y método de fabricación. Resumiendo, el proceso implica doblar la pieza plegada bidimensional 70 alrededor de un mandril cilindrico o cónico y alterar el material para retener su forma tridimensional. Por ejemplo, diversas aleaciones de níquel-titanio (Nitinol) pueden ser fácilmente dobladas alrededor de un mandril y después fijadas en esa forma mediante tratamientos térmicos.Figure 4 describes in more detail various procedures and apparatus for converting a two-dimensional folded part, such as that shown in Figure 4, into the three-dimensional shape of Figure 5 in Patent Application Serial No. 10 / 251,651, filed on September 20, 2002 from the USA pending, and entitled Continuous Heart Valve Support Frame and Method of Manufacture. In summary, the process involves bending the two-dimensional bent 70 around a cylindrical or conical mandrel and altering the material to retain its three-dimensional shape. For example, various nickel-titanium (Nitinol) alloys can be easily bent around a mandrel and then fixed there by heat treatments.
En un ejemplo de realización del presente invento el armazón de soporte interno 50 de la válvula 22 está hecho de un material que es muy flexible para permitir el máximo movimiento relativo entre las valvas y las comisuras de la válvula, y en algunos casos permitir la contracción en un pequeño diámetro del perfil para una colocación mínimamente invasiva en un sitio de implantación. Al mismo tiempo el armazón de soporte debe poseer una mínima cantidad de rigidez para proporcionar al deseado soporte a las aletas. Por lo tanto, existe un equilibrio obtenido entre la flexibilidad requerida y la rigidez.In an exemplary embodiment of the present invention the internal support frame 50 of the valve 22 is made of a material that is highly flexible to allow maximum relative movement between the valve leaflets and commissures, and in some cases allow for contraction. in a small profile diameter for minimally invasive placement at an implantation site. At the same time the support frame must possess a minimal amount of stiffness to provide the desired fin support. Therefore, there is a balance obtained between the required flexibility and stiffness.
El material para el armazón interno de soporte es convenientemente “elástico”, lo que significa que tiene la capacidad de rebotar a partir de una deformación impuesta. Diversas aleaciones NITINOL son especialmente adecuadas para hacer el armazón interno de soporte del presente invento ya que en ciertas circunstancias están considerados que son “superelásticos”.The material for the internal support frame is conveniently "springy", which means that it has the ability to bounce from an imposed deformation. Various NITINOL alloys are especially suitable for making the internal support frame of the present invention as under certain circumstances they are considered to be "superelastic".
El término “superelástico” (a veces “seudoelástico”) se refiere a la propiedad de algunos materiales de soportar unas tensiones extremas (hasta el 8%) sin alcanzar su límite de tensión máxima de colapso. Algunas llamadas aleaciones con memoria de forma (SMAs) son conocidas para mostrar un fenómeno superelástico o un comportamiento similar al del caucho en el que una tensión obtenida más allá del límite elástico del material SMA durante la carga se recupera durante la descarga. Este fenómeno superelástico se produce cuando la carga es aplicada a un artículo SMA austenítico que primero se deforma elásticamente hasta el límite elástico del material SMA (a veces denominado como la tensión crítica). Tras la posterior imposición de carga el material SMA comienza a transformarse en martensita con tensión provocada o “SIM”. Esta transformación tiene lugar a una tensión esencialmente constante, hasta el punto en el que el material SMA está completamente transformado en martensita. Cuando se retira la tensión el material SMA volverá de nuevo a austenita y el artículo volverá a su forma preprogramada o memorizada.The term "superelastic" (sometimes "pseudoelastic") refers to the property of some materials to withstand extreme stresses (up to 8%) without reaching their maximum collapse stress limit. Some so-called shape memory alloys (SMAs) are known to show a superelastic phenomenon or rubber-like behavior in which a stress obtained beyond the elastic limit of the SMA material during charging is recovered during discharge. This superelastic phenomenon occurs when load is applied to an austenitic SMA article that first deforms elastically to the elastic limit of the SMA material (sometimes referred to as the critical stress). After subsequent loading, the SMA material begins to transform into stress induced martensite or "SIM". This transformation takes place at an essentially constant voltage, up to the point where the SMA material is completely transformed into martensite. When the stress is removed the SMA material will revert back to austenite and the item will return to its pre-programmed or memorized shape.
El armazón de soporte 50 está realizado de un material que muestra una histéresis en la zona elástica y/o superelástica. La “histéresis” indica que cuando el material está deformado más allá del “estado de memoria” (definida como una geometría no forzada) produce una curva tensión-deformación que es diferente y mayor que la curva tensión-deformación producida cuando el material intenta volver a su estado de memoria. Un ejemplo de un material que muestra tal histéresis es el NITINOL. La presencia de esta histéresis implica que requiere una fuerza mayor para desplazar el material desde su estado de memoria que la que el material ejerce cuando vuelve a su estado de memoria.Support frame 50 is made of a material that exhibits hysteresis in the elastic and / or superelastic region. The "hysteresis" indicates that when the material is deformed beyond the "memory state" (defined as an unforced geometry) it produces a stress-strain curve that is different and greater than the stress-strain curve produced when the material tries to return. to your memory state. An example of a material that exhibits such hysteresis is NITINOL. The presence of this hysteresis implies that it requires a greater force to move the material from its memory state than the material exerts when it returns to its memory state.
Cuando se usa el NITINOL la fijación de la forma se hace a una temperatura particular durante un periodo de tiempo establecido para asegurar ciertas propiedades en el material. Es decir, la temperatura de transición martensítica es convenientemente menor que la temperatura ambiente y la temperatura de transición austenítica es convenientemente menor que la temperatura corporal. Por ejemplo, la temperatura por debajo de la cual el material está en forma de martensita es alrededor de 02-52 C, en tanto que la temperatura por encima de la cual el material se encuentra en forma de austenita es alrededor de 202-252 C. Cuando al material se la ha fijado la forma de este modo, la válvula de corazón 22 puede ser enfriada, por ejemplo en un baño de hielo, justo antes de que el implante cambie la estructura cristalina del armazón de soporte 50 a martensita y cree una alta flexibilidad para permitir su compactación en un perfil de colocación con un pequeño diámetro. Después del implante y expansión la temperatura asciende desde la temperatura corporal por encima de la temperatura de transición austenítica y de este modo el armazón de soporte 50 posee el grado deseado de rigidez para soportar adecuadamente las aletas. When NITINOL is used, the fixation of the shape is done at a particular temperature for a set period of time to ensure certain properties in the material. That is, the martensitic transition temperature is conveniently lower than room temperature and the austenitic transition temperature is conveniently lower than body temperature. For example, the temperature below which the material is in the form of martensite is around 02-52 C, while the temperature above which the material is in the form of austenite is around 202-252 C When the material has been shaped in this way, the heart valve 22 can be cooled, for example in an ice bath, just before the implant changes the crystalline structure of the supporting framework 50 to martensite and creates high flexibility to allow compaction in a laying profile with a small diameter. After implantation and expansion the temperature rises from body temperature above the austenitic transition temperature and thus the support frame 50 possesses the desired degree of rigidity to adequately support the fins.
El armazón de soporte 50 (y la pieza plegada 70) incluye un armazón de aleta 72 definido por tres zonas de valva 74 intermedias de las tres zonas de comisura 76. En la Figura 4 el armazón 72 de aleta en la pieza plegada 70 muestra una forma de trébol de tres hojas, en tanto que en la Figura 5 el armazón 72 de aleta tiene una forma continua y ondulante como la anteriormente descrita. En la Figura 4 puede verse una segunda forma de trébol de tres hojas constituido por los tres conectores 40 y los tres posicionadores de valva 42. Cuando están dobladas en la configuración tridimensional de la Figura 5 se pueden ver dos formas continuas ondulantes orientadas formando 60° entre sí con respecto al eje de flujo. Cada conector de valva 40 incluye un ápice 90 y un par de patillas 92 que se fijan rígidamente al armazón de aletas 72 en los puntos de unión 94. En la realización preferida e ilustrada los puntos de unión 84 y 94 son coincidentes.Support frame 50 (and folded part 70) includes a fin frame 72 defined by three leaflet zones 74 intermediate the three commissure zones 76. In Figure 4 the fin frame 72 on folded part 70 shows a three-leaf clover shape, while in Figure 5 the fin frame 72 has a continuous, undulating shape as described above. In Figure 4 you can see a second three-leaf clover shape made up of the three connectors 40 and the three leaflet positioners 42. When folded in the three-dimensional configuration of Figure 5, two continuous undulating shapes oriented forming 60 ° can be seen. relative to the flow axis. Each leaflet connector 40 includes an apex 90 and a pair of pins 92 that are rigidly attached to the wing frame 72 at attachment points 94. In the preferred and illustrated embodiment, attachment points 84 and 94 are coincident.
Las Figuras 5A y 5B muestran unas configuraciones del posicionador de valvas alternativas del armazón de soporte 50 de válvula de corazón tridimensional de la Figura 5. Como se ha mencionado antes, los miembros antimigración facilitan el anclaje del armazón de soporte 50 a la anatomía circundante, e impiden el movimiento axial y de giro de la válvula 22. Los miembros antimigración 56 mostrados en la Figura 5 sobresalen generalmente de forma axial en la dirección de entrada desde el ápice 90 de cada posicionador de valva 42. En la Figura 5A un segundo miembro antimigración 57 sobresale generalmente de forma axial en la dirección de salida desde el ápice 90 de cada posicionador de valva 42. En la Figura 5B hay varios miembros antimigración 56 que se extienden generalmente de forma axial en la dirección de entrada. Se han considerado diversas combinaciones, colocaciones y orientaciones de estos ejemplos, y los ejemplos no deberían ser considerados como limitativos.Figures 5A and 5B show alternate leaflet positioner configurations of the three-dimensional heart valve support frame 50 of Figure 5. As mentioned above, the anti-migration members facilitate anchoring of the support frame 50 to the surrounding anatomy, and prevent axial and rotational movement of the valve 22. The anti-migration members 56 shown in Figure 5 protrude generally axially in the inlet direction from the apex 90 of each leaflet positioner 42. In Figure 5A a second member antimigration 57 protrudes generally axially in the exit direction from the apex 90 of each leaflet positioner 42. In Figure 5B there are a number of antimigration members 56 extending generally axially in the entry direction. Various combinations, placements, and orientations of these examples have been considered, and the examples should not be construed as limiting.
La Figura 6A muestra la válvula 22 casi completamente montada pero sin las anteriormente mencionadas cubiertas de tela 54 que se ven en la válvula totalmente montada de la Figura 6B. Las cubiertas 54 ayudan a impedir la filtración de sangre alrededor de la válvula implantada 22, y específicamente en las áreas entre cada par de valvas 30.Figure 6A shows the valve 22 almost completely assembled but without the aforementioned cloth covers 54 seen in the fully assembled valve of Figure 6B. Covers 54 help prevent blood leakage around implanted valve 22, and specifically in the areas between each pair of leaflets 30.
La Figura 7 ilustra una vista en planta de un ejemplo de aleta 52. El borde libre 50 se muestra como lineal, aunque también puede ser arqueada, trapezoidal o de cualquier otra configuración. Cada aleta incluye un par de lengüetas rectangulares opuestas 100 en uno u otro extremo del borde libre 53. Un borde de valva arqueado 102 se extiende entre las lengüetas 100 y opuesta al borde libre 53. Las lengüetas 100 y el borde de valva arqueado 102 están fijadas a la válvula 22, y específicamente a lo largo de los contornos del armazón de aleta 72 visto en la Figura 5. Figure 7 illustrates a plan view of an example fin 52. Free edge 50 is shown as linear, although it may also be arcuate, trapezoidal, or any other configuration. Each fin includes a pair of opposing rectangular tabs 100 at either end of free edge 53. An arcuate leaflet edge 102 extends between tabs 100 and opposite free edge 53. Tabs 100 and arcuate leaflet edge 102 are attached to valve 22, and specifically along the contours of flap frame 72 seen in Figure 5.
La Figura 8 es una vista de una sección ampliada de una de las comisuras 32 de la válvula 22 tomada a lo largo de la línea 8-8 de la Figura 3B y que muestra su estructura interna. La zona 76 de la comisura del armazón 72 de aleta se hace cónica hacia abajo en la dirección de la salida hacia una punta cerrada 104. Los ensanchamientos de fijación 106 están formados contiguos a la punta 104 y convenientemente incluyen una pluralidad de agujeros de montaje 108 dimensionados para permitir el paso de suturas a través de ellos. Las aletas contiguas 52 se juntan en las zonas de comisura 76 y sus lengüetas 100 se despliegan separándose una de otra en el exterior de los ensanchamientos 106.Figure 8 is an enlarged sectional view of one of the commissures 32 of valve 22 taken along line 8-8 of Figure 3B and showing its internal structure. The commissure region 76 of the fin frame 72 tapers downward in the direction of the outlet toward a closed tip 104. The attachment flares 106 are formed contiguous with the tip 104 and conveniently include a plurality of mounting holes 108 sized to allow sutures to pass through. The adjoining flaps 52 meet at the commissure areas 76 and their tabs 100 unfold away from each other on the outside of the flares 106.
Como se ve en la Figura 9, el borde 102 de la valva de cada aleta 52 se fija con las suturas 110 a un ensanchamiento de tela 112 de una cubierta de tejido textil 114 tubular alrededor del armazón 72 de aleta. Esta configuración hace que las fuerzas de tracción comunicadas por las aletas 52 sean transferidas lo más que se pueda al armazón 72 más que ser principalmente soportadas por las suturas de fijación 110.As seen in Figure 9, the edge 102 of the leaflet of each flap 52 is secured with sutures 110 to a fabric swell 112 of a tubular textile fabric covering 114 around flap frame 72. This configuration causes the pulling forces communicated by the flaps 52 to be transferred as much as possible to the frame 72 rather than being primarily supported by the fixation sutures 110.
La Figura 10 muestra la estructura de fijación en la punta 104 de la comisura, y específicamente ilustra las suturas 120 que atraviesan la cubierta de tejido textil 114 a través de los agujeros de montaje 108 y a través de las lengüetas 100 de la aleta plegada. Una segunda sutura 122 pasa a través del ensanchamiento de tela 112, de la lengüeta 100 de la aleta, y de las cubiertas de tela 54 (también vistas en la Figura 6B). Debido a que cada una de las aletas 52 incluye la lengüeta 100 que se extiende hacia fuera del armazón 72 de aleta, las fuerzas grandes que se ven con el cierre de la válvula es probable que tiren menos de las suturas 120 a través de las lengüetas. Esto es, la estructura mostrada en la Figura 10 hace que las fuerzas de tracción comunicadas por las aletas 52 sean transferidas lo máximo posible de las suturas 120, 122 al armazón 72, ayudando de este modo a impedir la rotura de las aletas flexibles y hacer que la válvula 22 sea más resistente.Figure 10 shows the attachment structure at the commissure tip 104, and specifically illustrates the sutures 120 traversing the fabric cover 114 through the mounting holes 108 and through the tabs 100 of the folded flap. A second suture 122 passes through fabric flap 112, flap tab 100, and fabric covers 54 (also seen in Figure 6B). Because each of the flaps 52 includes the tab 100 that extends outward from the flap frame 72, the large forces seen with closing the valve are likely to pull less of the sutures 120 through the tabs. . That is, the structure shown in Figure 10 causes the pulling forces communicated by the flaps 52 to be transferred as much as possible from the sutures 120, 122 to the frame 72, thereby helping to prevent breakage of the flexible flaps and make make valve 22 stronger.
Las Figuras 11 y 12 ilustran esquemáticamente una técnica para cargar una válvula de corazón protésica del presente invento en un tubo de colocación. En beneficio de la claridad se muestra solamente el armazón de soporte 50 estando cargado en el tubo de colocación 20. Una pluralidad de suturas o de otros tales miembros flexibles o filamentos 130 se muestran enlazados a través de cada una de las zonas 76 de comisura del armazón de soporte 50. Estos filamentos 130 se extienden en el extremo distal del tubo de colocación 20 y a través de su luz hasta un extremo proximal (no mostrado) en donde están conectados a un dispositivo tensionador. En uso real los filamentos 130 pasarían a través de las comisuras 32 de la válvula 22 evitando las aletas flexibles. Un adaptador de carga 132 se acopla al extremo distal del tubo de colocación 20. El adaptador 132 incluye una abertura 134 en forma de embudo. La tensión en los filamentos 130 tira de las comisuras 32 de la válvula hacia el interior de la abertura 134 en forma de embudo que comprime gradualmente la válvula a un diámetro menor que la luz del tubo de colocación 20. Una vez que la válvula 22 está posicionada totalmente dentro del tubo de colocación 20, como se ve en la Figura 12, los filamentos 130 y el adaptador 132 son retirados. Figures 11 and 12 schematically illustrate a technique for loading a prosthetic heart valve of the present invention into a delivery tube. For the sake of clarity, only the support frame 50 is shown being loaded into the delivery tube 20. A plurality of sutures or other such flexible members or filaments 130 are shown looped through each of the commissure areas 76 of the support frame 50. These filaments 130 extend at the distal end of delivery tube 20 and through its lumen to a proximal end (not shown) where they are connected to a tensioning device. In actual use the filaments 130 would pass through the commissures 32 of the valve 22 avoiding the flexible fins. A charging adapter 132 attaches to the distal end of delivery tube 20. Adapter 132 includes a funnel-shaped opening 134. The tension in the filaments 130 pulls the commissures 32 of the valve into the funnel-shaped opening 134 which gradually compresses the valve to a diameter smaller than the lumen of the placement tube 20. Once the valve 22 is fully positioned within placement tube 20, as seen in Figure 12, filaments 130 and adapter 132 are removed.
Las Figuras 13-17 ilustran un elemento de sujeción mínimamente invasivo para uso con las válvulas de corazón protésicas del presente invento. Las Figuras 13A y 13B muestran la fijación del elemento de sujeción 150 a la válvula de corazón 22 como se ha descrito antes. El soporte 150 incluye una parte flexible 152 con varios brazos y una parte rígida 154 (vista en las Figuras 17A-17B). La parte flexible 152 incluye una pluralidad, al menos tres, pero preferiblemente son seis los miembros o brazos flexibles 156 que se extienden hacia fuera desde un disco circular central 158. Cada uno de los brazos 156 termina en un extremo redondeado que tiene una abertura de fijación 160. Los brazos 156 están distribuidos uniformemente alrededor de la circunferencia del disco circular 15, y están dispuestos para fijarse a cada uno de los extremos de las comisuras 32 y a los posicionadores de valva 42 de la válvula 22. Para este fin se usan las suturas liberables 162 u otra estructura de fijación similar.Figures 13-17 illustrate a minimally invasive fastener for use with the prosthetic heart valves of the present invention. Figures 13A and 13B show the attachment of fastener 150 to heart valve 22 as described above. Bracket 150 includes a flexible portion 152 with multiple arms and a rigid portion 154 (seen in Figures 17A-17B). Flexible portion 152 includes a plurality, at least three, but preferably six, flexible members or arms 156 extending outwardly from a central circular disk 158. Each of the arms 156 terminates in a rounded end having an opening for attachment 160. Arms 156 are evenly distributed around the circumference of circular disc 15, and are arranged to attach to each end of commissures 32 and to the leaflet positioners 42 of valve 22. releasable sutures 162 or other similar attachment structure.
La Figura 14 muestra el soporte 150 y la válvula 22 montados saliendo del extremo distal del tubo de colocación 20. Antes de esta etapa los miembros o brazos flexibles 156 están orientados generalmente en dirección axial dentro del tubo 20 con la válvula 22 también comprimida y teniendo sus puntas de salida acopladas a los extremos distales de los brazos 156. Los brazos 156 del elemento de sujeción 150 son suficientemente flexibles para ser comprimidos hasta el perfil pequeño requerido para su colocación mediante el tubo de colocación 20. A este respecto la parte flexible 152 está convenientemente hecha de Nitinol. Un mango 170, que puede ser flexible o rígido, se fija al elemento de sujeción 150 para su manipulación. Desplazando el mango 170 en una dirección distal con respecto al tubo 20 expulsa por lo tanto la combinación válvula/soporte y la elasticidad de la válvula 22 y de los brazos de sujeción 156 hace que salten hacia afuera. Se sobreentiende que pueden utilizarse otros diseños del elemento de sujeción 150 tales como la sustitución de los brazos 156 de tipo muelle por miembros rígidos provistos de bisagras y desviados por medio de muelles.Figure 14 shows mount 150 and valve 22 mounted exiting the distal end of delivery tube 20. Prior to this step, flexible members or arms 156 are oriented generally in the axial direction within tube 20 with valve 22 also compressed and having its outlet tips coupled to the distal ends of the arms 156. The arms 156 of the clamp 150 are flexible enough to be compressed to the small profile required for placement by the placement tube 20. In this regard the flexible portion 152 it is conveniently made from Nitinol. A handle 170, which can be flexible or rigid, is attached to fastener 150 for manipulation. Moving handle 170 in a distal direction relative to tube 20 therefore ejects the valve / holder combination and the elasticity of valve 22 and clamp arms 156 causes them to spring outward. It is understood that other designs of fastener 150 may be used such as the replacement of spring-type arms 156 with rigid, spring-biased, hinged members.
Las Figuras 15-17 ilustran detalles de ejemplos de la parte flexible 152 y de la parte rígida 154. En una configuración relajada la parte flexible 152 es plana y puede ser cortada de una hoja de Nitinol. La parte rígida 154 incluye una cara proximal 180 que está dimensionada aproximadamente igual que el disco circular 158, y lo suficientemente pequeña para ajustarse con el tubo de colocación 20. Un orificio central 182 perforado se abre en la cara proximal para recibir el mango 170. La Figura 15 ilustra varias suturas 162 perforadas a través del elemento de sujeción 150 y usadas para acoplar dicho elemento de sujeción a las seis puntas salientes de la válvula de corazón protésica 22. Convenientemente, estas suturas 162 están ancladas con respecto al elemento de sujeción y cada una pasa sobre una guía de corte en el elemento de sujeción de forma que la sutura pueda ser cortada a lo largo de su punto medio dando lugar a dos extremos libres que puedan ser extraídos de la válvula.Figures 15-17 illustrate details of examples of flexible portion 152 and rigid portion 154. In a relaxed configuration, flexible portion 152 is flat and can be cut from Nitinol sheet. Rigid portion 154 includes a proximal face 180 that is sized approximately the same as circular disk 158, and small enough to fit with delivery tube 20. A central hole 182 is drilled in the proximal face to receive handle 170. Figure 15 illustrates various sutures 162 pierced through the fastener 150 and used to couple said fastener to the six protruding tips of the prosthetic heart valve 22. Conveniently, these sutures 162 are anchored relative to the fastener and each passes over a cutting guide in the fastener so that the suture can be cut along its midpoint resulting in two free ends that can be removed from the valve.
El elemento de sujeción 150 es suficientemente flexible para ser comprimido a un pequeño perfil y pasados a través del tubo de colocación 20. Al mismo tiempo, la parte flexible 152 y los varios brazos flexibles 156 tienen un grado suficiente de resistencia a la torsión para permitir que el operador gire la válvula 22 durante el procedimiento de implante. Además, los brazos 156 tienen una forma para hacer contacto con la boca distal del tubo de colocación 20 cuando se tira del conjunto hacia el tubo, el cual, debido a su rigidez radial, hace que los brazos se doblen hacia atrás a su orientación axial dentro del tubo. Como los extremos distales de los brazos están acoplados a al menos tres de las puntas de salida de la válvula de corazón protésica 22, la válvula se estrecha en consecuencia. El estrechamiento de la válvula 22 después de haber sido totalmente expulsada del extremo del tubo de colocación y expandida permite el reposicionamiento de la válvula 22. Esto es, los posicionadores de valva 42 están diseñados para hacer contacto con las cavidades del seno o la pared aórtica después de haberse expandido la válvula 22, y la opción retracción/estrechamiento proporcionada por el soporte 150 puede ser necesaria para desaplicar los posicionadores de valva del tejido circundante para reposicionar o reorientar la válvula. Además, la válvula 22 puede ser completamente comprimida y replegada hacia el tubo de colocación para permitir la retirada en caso de que el cirujano o cardiólogo considere que por algún motivo la válvula no es adecuada.The fastener 150 is flexible enough to be compressed to a small profile and passed through the placement tube 20. At the same time, the flexible portion 152 and the various flexible arms 156 have a sufficient degree of torsional resistance to allow have the operator rotate valve 22 during the implant procedure. In addition, the arms 156 are shaped to contact the distal mouth of the delivery tube 20 when the assembly is pulled into the tube, which, due to its radial stiffness, causes the arms to flex back to their axial orientation. inside the tube. Since the distal ends of the arms are coupled to at least three of the outlet tips of the prosthetic heart valve 22, the valve narrows accordingly. The constriction of valve 22 after it has been fully expelled from the end of the delivery tube and expanded allows repositioning of valve 22. That is, the leaflet positioners 42 are designed to contact the sinus cavities or the aortic wall. after valve 22 has expanded, and the retraction / narrowing option provided by bracket 150 may be necessary to disengage the leaflet positioners from surrounding tissue to reposition or reorient the valve. In addition, valve 22 can be fully compressed and retracted into the delivery tube to allow removal in the event the surgeon or cardiologist deems the valve unsuitable for any reason.
Método de usoMethod of use
Antes del implante el cirujano de corazón o cardiólogo mide el anillo de la válvula aórtica AV usando medidores apropiados, mínimamente invasivos o no según sea el caso, varios de los cuales están disponibles y no serán descritos aquí más. La válvula correctamente dimensionada es después seleccionada y comprimida introduciéndola en el catéter o tubo de colocación 20, tal como con el uso del adaptador de carga 132 que tiene la abertura 134 en forma de embudo, como se ve en la Figura 11. Para facilitar el paso de carga, el armazón de soporte 50 de la válvula 20 debe ser capaz de resistir altas tensiones sin fallo. Un método es formar el armazón de soporte 50 a partir de un material que tenga unas propiedades superelásticas, por ejemplo un Nitinol que tenga una temperatura de transición martensítica menor de aproximadamente 5° C y que pueda ser sumergido en un baño de hielo para cambiar su estructura cristalina a martensita, que es una fase superelástica. Una vez cargado en el tubo de colocación 20, el armazón de soporte 50 no volverá a su forma original después de una subida de temperatura, y de este modo no ejercerá una fuerza no debida sobre el tubo. La válvula de corazón 22 puede ser cargada alrededor de un balón de inflado, pero a fin de conseguir un perfil pequeño el balón se usa después de la expulsión de la válvula del tubo en el lugar de implantación.Before implantation, the heart surgeon or cardiologist measures the annulus of the AV aortic valve using appropriate gauges, minimally invasive or not as the case may be, several of which are available and will not be described further here. The properly sized valve is then selected and compressed by inserting it into the catheter or delivery tube 20, such as with the use of the loading adapter 132 having the funnel-shaped opening 134, as seen in Figure 11. To facilitate load passage, the support frame 50 of the valve 20 must be able to withstand high stresses without failure. One method is to form the support frame 50 from a material that has superelastic properties, for example a Nitinol that has a martensitic transition temperature of less than about 5 ° C and that can be immersed in an ice bath to change its crystalline structure to martensite, which is a superelastic phase. Once loaded into the placement tube 20, the support frame 50 will not return to its original shape after a rise in temperature, and thus will not exert an undue force on the tube. Heart valve 22 can be loaded around an inflation balloon, but in order to achieve a small profile the balloon is used after ejection of the valve from the tube at the implantation site.
Con referencia de nuevo a la Figura 1, el tubo de colocación 20 se ve en posición justo antes de llevar a cabo la expulsión y expansión de la válvula de corazón protésica 22 desde un extremo distal de él para su implante en el anillo de la válvula aórtica AV. El extremo distal del tubo de colocación 20 puede opcionalmente ser estabilizado por un balón 24 (mostrado superpuesto en líneas de puntos) inflado contra la luz de la aorta ascendente AA, o con otros medios. El tubo de colocación 20 es preferiblemente insertado en la vasculatura del paciente usando un introductor 26 de mayor diámetro a través de un vaso periférico tal como la arteria femoral o vena femoral. Alternativamente, el vaso periférico puede ser la vena yugular interna, la arteria subclaviana, la arteria axilar, la aorta abdominal, la aorta descendente, o cualquier otro vaso sanguíneo apropiado. El introductor 26 puede ser insertado mediante un corte quirúrgico o percutáneamente usando la técnica de Seldinger.Referring again to Figure 1, delivery tube 20 is seen in position just prior to carrying out delivery and expansion of prosthetic heart valve 22 from a distal end thereof for implantation in the valve annulus. aortic AV. The distal end of the delivery tube 20 may optionally be stabilized by a balloon 24 (shown overlaid in dotted lines) inflated against the lumen of the ascending aorta AA, or by other means. Delivery tube 20 is preferably inserted into the patient's vasculature using a larger diameter introducer 26 through a peripheral vessel such as the femoral artery or femoral vein. Alternatively, the peripheral vessel can be the internal jugular vein, the subclavian artery, the axillary artery, the abdominal aorta, the descending aorta, or any other appropriate blood vessel. Introducer 26 can be inserted via a surgical cut or percutaneously using the Seldinger technique.
La válvula de corazón protésica 22 es expulsada del tubo de colocación 20 por un movimiento relativo entre ellos, es decir empujando la válvula del tubo o plegando el tubo desde alrededor de la válvula. La válvula 22 convenientemente se expande hasta hacer contacto con la pared circundante de la luz, pero puede también ser ayudada por un balón hinchable o por cualquier otro expansor físico.The prosthetic heart valve 22 is expelled from the delivery tube 20 by a relative movement between them, ie by pushing the valve out of the tube or by folding the tube from around the valve. Valve 22 conveniently expands to contact the surrounding wall of the lumen, but may also be assisted by an inflatable balloon or any other physical expander.
Con referencia a las Figuras 2A y 2B, los posicionadores de valva 42 ayudan a guiar la válvula de corazón protésica 22 hasta su posición en el anillo de la válvula aórtica AV. Como se ha mencionado antes, los posicionadores de valva 42 convenientemente se ensanchan hacia fuera desde el resto de la estructura de la válvula y de este modo se configuran para hacer contacto con los senos de la válvula aórtica AV mientras que las valvas 30 están dimensionadas para ajustarse en el anillo. De acuerdo con un método de implante, el cirujano o cardiólogo expulsa la válvula de corazón 22 hacia abajo (es decir, hacia el ventrículo izquierdo) de su posición de implante óptima, y después desplaza axialmente la válvula hacia arriba a la posición deseada. Dicho de otra forma, la válvula de corazón 22 se expande en un lugar que es inferior a una posición de implante final de forma que los posicionadores de valva 42 hacen contacto con el anillo aórtico circundante, y la válvula es después reposicionada desplazándola en una dirección hacia arriba a la posición de implante. A medida que asciende la válvula 22 los posicionadores de valva 42 saltan hacia fuera introduciéndose en los tres senos de la válvula y ayudan a orientar la válvula mediante un giro. Esto es, los senos canalizan los posicionadores de valva 42 y corrigen cualquier falta de alineación de giro. Finalmente la válvula 22 es implantada con los posicionadores de valva 42 en las cavidades de los senos (preferiblemente debajo de la ostia coronaria CO) y las valvas 30 y los conectores de valva 40 que forman una pared de contacto ondulado continuo con el anillo o raíz de la válvula aórtica AV.Referring to Figures 2A and 2B, the leaflet positioners 42 help guide the prosthetic heart valve 22 into position on the annulus of the AV aortic valve. As mentioned above, the leaflet positioners 42 conveniently flare outward from the remainder of the valve structure and thus are configured to contact the sinuses of the AV aortic valve while the leaflets 30 are sized to fit on the ring. In accordance with one implantation method, the surgeon or cardiologist ejects the heart valve 22 downward (ie, toward the left ventricle) from its optimal implantation position, and then axially displaces the valve upward to the desired position. In other words, the heart valve 22 is expanded to a location that is less than a final implant position so that the leaflet positioners 42 make contact with the surrounding aortic annulus, and the valve is then repositioned by moving it in one direction. up to the implant position. As the valve 22 rises the leaflet positioners 42 spring out into the three sinuses of the valve and help orient the valve by twisting. That is, the sinuses channel the leaflet positioners 42 and correct for any rotational misalignment. Finally the valve 22 is implanted with the leaflet positioners 42 in the sinus cavities (preferably below the coronary ostia CO) and the leaflets 30 and the leaflet connectors 40 that form a wall of continuous wavy contact with the annulus or root. of the AV aortic valve.
Como se ha mencionado, un expansor físico (por ejemplo, un balón) puede ser usado para expandir radialmente hacia fuera la válvula 22 (incluido el armazón de soporte interno) más allá de su diámetro autoexpandido de forma que esté firmemente anclado en su posición. Una válvula protésica con histéresis que se mantenga en un diámetro reducido (primero o estrechado) ejercerá una fuerza radial hacia fuera que es menor que la que resistirá en una fuerza radial hacia dentro. Por lo tanto, si se despliega “in situ”, no se espera que el dispositivo ejerza una fuerza suficiente sobre la pared del vaso para expandirlo hasta el diámetro deseado. No obstante, si la expansión es ayudada por medio de un balón u otro expansor físico, la histéresis del material le permitirá conservar mejor su diámetro una vez que se ha conseguido el diámetro. Esto es diferente para un dispositivo autoexpansible que depende únicamente de la fuerza radial hacia fuera del dispositivo para conseguir su diámetro deseado. También es diferente para los dispositivos expandidos que dependen de un balón para deformar plásticamente el dispositivo a su diámetro deseado. Aunque fuera posible que se pudiera usar un balón u otro expansor físico en un dispositivo autoexpansible de un material que no mostrara una histéresis, las ventajas no serían tan grandes.As mentioned, a physical expander (eg, a balloon) may be used to radially outwardly expand valve 22 (including the internal support frame) beyond its self-expanding diameter so that it is firmly anchored in position. A prosthetic valve with hysteresis that is kept at a reduced diameter (first or tapered) will exert an outward radial force that is less than it will resist in an inward radial force. Therefore, if deployed "in situ", the device is not expected to exert a sufficient force on the vessel wall to expand it to the desired diameter. However, if expansion is aided by means of a balloon or other physical expander, the hysteresis of the material will allow it to better retain its diameter once the diameter has been achieved. This is different for a self-expanding device that relies solely on the radial force outward from the device to achieve its desired diameter. It is also different for expanded devices that rely on a balloon to plastically deform the device to its desired diameter. Although it was possible that a balloon or other physical expander could be used in a self-expanding device made of a material that does not show hysteresis, the advantages would not be that great.
Se apreciará que el invento ha sido descrito con referencia a ciertos ejemplos o realizaciones preferidas tal como se ha mostrado en los dibujos. Se pueden realizan añadidos, supresiones, cambios y alteraciones en las realizaciones y ejemplos antes descritos, y se pretende que tales adiciones, eliminaciones, cambios y alteraciones queden incluidas dentro del alcance de las siguientes reivindicaciones. It will be appreciated that the invention has been described with reference to certain examples or preferred embodiments as shown in the drawings. Additions, deletions, changes, and alterations may be made to the above-described embodiments and examples, and such additions, deletions, changes, and alterations are intended to be included within the scope of the following claims.
Claims (10)
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US10/390,951 US7399315B2 (en) | 2003-03-18 | 2003-03-18 | Minimally-invasive heart valve with cusp positioners |
US390951 | 2003-03-18 |
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ES2402881T5 true ES2402881T5 (en) | 2020-11-24 |
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ES04757521T Expired - Lifetime ES2375133T3 (en) | 2003-03-18 | 2004-03-17 | MINIMALLY INVASIVE HEART VALVE WITH VALVE POSITIONERS. |
ES10164361T Expired - Lifetime ES2402881T5 (en) | 2003-03-18 | 2004-03-17 | Minimally invasive heart valve with leaflet positioners |
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ES04757521T Expired - Lifetime ES2375133T3 (en) | 2003-03-18 | 2004-03-17 | MINIMALLY INVASIVE HEART VALVE WITH VALVE POSITIONERS. |
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2003
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2004
- 2004-03-17 WO PCT/US2004/008053 patent/WO2004082527A2/en active Application Filing
- 2004-03-17 DK DK10164361.7T patent/DK2241287T5/en active
- 2004-03-17 EP EP10164361.7A patent/EP2241287B2/en not_active Expired - Lifetime
- 2004-03-17 DK DK04757521.2T patent/DK1603493T3/en active
- 2004-03-17 ES ES04757521T patent/ES2375133T3/en not_active Expired - Lifetime
- 2004-03-17 ES ES10164361T patent/ES2402881T5/en not_active Expired - Lifetime
- 2004-03-17 AT AT04757521T patent/ATE538761T1/en active
- 2004-03-17 EP EP04757521A patent/EP1603493B1/en not_active Expired - Lifetime
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2008
- 2008-07-09 US US12/170,341 patent/US8778018B2/en active Active
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2012
- 2012-10-09 US US13/648,119 patent/US9320598B2/en not_active Expired - Fee Related
- 2012-10-16 US US13/653,201 patent/US9504567B2/en not_active Expired - Lifetime
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2016
- 2016-03-04 US US15/061,895 patent/US9675455B2/en not_active Expired - Lifetime
- 2016-04-25 US US15/138,115 patent/US9724193B2/en not_active Expired - Lifetime
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2017
- 2017-07-05 US US15/641,991 patent/US10299925B2/en not_active Expired - Lifetime
- 2017-08-07 US US15/670,778 patent/US10159567B2/en not_active Expired - Lifetime
- 2017-12-05 US US15/832,633 patent/US20180092741A1/en not_active Abandoned
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2019
- 2019-05-24 US US16/422,749 patent/US11234815B2/en not_active Expired - Lifetime
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2022
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